Eculizumab

Generic Name
Eculizumab
Brand Names
Soliris, Epysqli, Bekemv
Drug Type
Biotech
Chemical Formula
-
CAS Number
219685-50-4
Unique Ingredient Identifier
A3ULP0F556
Background

Eculizumab is a monoclonal antibody that targets complement protein C5. Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions.
...

Indication

Eculizumab is indicated in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy, and neuromyelitis optica spectrum disorder (NMOSD). It is also indicated in EU to treat PNH in both adult and pediatric patients.

Associated Conditions
Generalized Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders, Paroxysmal Nocturnal Haemoglobinuria (PNH), Thrombotic Microangiopathies
Associated Therapies
-

Eculizumab in Shiga-toxin Related Hemolytic and Uremic Syndrome Pediatric Patients - ECULISHU

First Posted Date
2014-07-31
Last Posted Date
2019-07-12
Lead Sponsor
University Hospital, Toulouse
Target Recruit Count
100
Registration Number
NCT02205541
Locations
🇫🇷

Clocheville Hospital, Tours, France

🇫🇷

Pellegrin Hospital, Bordeaux, France

🇫🇷

Trousseau Hospital, Paris, France

and more 10 locations

Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-05-22
Last Posted Date
2018-12-17
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
288
Registration Number
NCT02145182
Locations
🇧🇷

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

Eculizumab in Primary MPGN

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-03-21
Last Posted Date
2018-01-17
Lead Sponsor
Mario Negri Institute for Pharmacological Research
Target Recruit Count
10
Registration Number
NCT02093533
Locations
🇮🇹

Policlinico "Federico II" - U.O. Nefrologia, Napoli, Italy

🇮🇹

Ospedale degli Infermi - U.O. Nefrologia e Dialisi, Rimini, Italy

🇮🇹

C.I. Columbus-Università Cattolica del S.Cuore - UOC Nefrologia e Dialisi, Roma, Italy

and more 10 locations

Inhibition of Complement Activation (Eculizumab) in Guillain-Barre Syndrome Study

Phase 2
Conditions
Interventions
First Posted Date
2014-01-07
Last Posted Date
2014-09-23
Lead Sponsor
NHS Greater Glasgow and Clyde
Target Recruit Count
30
Registration Number
NCT02029378
Locations
🇬🇧

Southern General Hospital, Glasgow, United Kingdom

The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation

First Posted Date
2013-12-17
Last Posted Date
2021-05-03
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
36
Registration Number
NCT02013037
Locations
🇺🇸

Cedars Sinai Medical Center, Heart Institute, Los Angeles, California, United States

Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation

First Posted Date
2013-08-09
Last Posted Date
2018-02-27
Lead Sponsor
Heeger, Peter, M.D.
Target Recruit Count
21
Registration Number
NCT01919346
Locations
🇺🇸

Yale - New Haven Hospital, New Haven, Connecticut, United States

🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

and more 2 locations

Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation

First Posted Date
2013-07-10
Last Posted Date
2017-09-21
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
11
Registration Number
NCT01895127
Locations
🇺🇸

UCSF Medical Center, San Francisco, California, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

University of Michigan Medical Center, Ann Arbor, Michigan, United States

A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

First Posted Date
2013-07-04
Last Posted Date
2019-06-26
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
143
Registration Number
NCT01892345
Locations
🇺🇸

John Hopkins University School of Medicine, Baltimore, Maryland, United States

🇦🇺

University of Sydney, Brain and Mind Center, Camperdown, New South Wales, Australia

🇦🇺

St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia

and more 67 locations

The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-12-31
Last Posted Date
2017-03-10
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
2
Registration Number
NCT01757431
Locations
🇯🇵

Nagano Red Cross Hospital, Nagano, Japan

🇯🇵

Tokyo Medical and Dental University Hospital, Tokyo, Japan

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